Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of venetoclax on participants receiving a covalent bruton's tyrosine kinase inhibitor (cbtki) for first-line chronic lymphocytic leukemia (1l cll) to achieve deep durable remissions to allow off-treatment period.

Conditions: Chronic Lymphocytic Leukemia

Summary: the main purpose of the study is to evaluate if adding venetoclax to participants receiving cbtki for the 1l cll can achieve deep durable remissions of undetectable measurable residual disease \[umrd \< or 10\^-4 in peripheral blood (pb)\] by end of combination treatment (eoct) to allow off-treatment period. the acronym brave stands for btki responders to achieve deep remission (or off-treatment periods) with venetoclax.


Eligibility criteria:
inclusion criteria: 1. diagnosed with cll and currently receiving a stable dose of cbtki (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1l treatment with a response of at least a pr per iwcll criteria 2. eastern cooperative oncology group (ecog) performance score of less than or equal to (\</=) 2 3. adequate renal and liver function exclusion criteria: 1. prior b-cell lymphoma (bcl-2) inhibitor therapy 2. anti-cluster of differentiation 20 (cd20) therapy within the month prior to screening 3. progressive or stable disease on cbtki 4. transformation of cll to aggressive non-hodgkin lymphoma (nhl) (richter's transformation or pro-lymphocytic leukemia) 5. history of cardiomyopathy 6. hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose) 7. clinically significant cardiovascular disease 8. active bleeding or history of bleeding diathesis 9. pregnant women and nursing mothers 10. uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
african-american heart failure trial

Conditions: Congestive Heart Failure

Summary: a placebo-controlled trial of bidil added to standard therapy in african-american patients with heart failure.

the overall objective is confirmation of bidil's safety and efficacy in african-american (afa) patients with moderate to severe symptomatic heart failure.

Eligibility criteria:
* african american male or female 18 years or older. * nyha class 3 \& 4. * have either a resting lvef less than or equal to 35% (by any method) or a resting lvidd greater than 2.9 cm/m2 bsa (or greater than 6.5 cm) with lvef less than 45% (by echocardiogram).
shr-1210 plus apatinib in patients with hepatocellular carcinoma after surgery

Conditions: Hepatocellular Carcinoma

Summary: shr-1210 is a humanized anti-pd1 immunoglobulin g4 (igg4) monoclonal antibody. this is an open- label，single center ，non-randomized ，single arm exploratory study . this clinical study is an investigator-initiatedclini-cal trial（iit ）.the objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-pd-1 antibody shr-1210 and apatinib in patients with barcelona clinic liver cancer (bclc) b\&c stage hepatocellular carcinoma after surgery.


Eligibility criteria:
inclusion criteria: 1. age:18-75 years, male or femal. 2. hepatocellular carcinoma confirmed by histopathology, child-pugh a . 3. bclc staging is stage b or c, preoperative assessment of no extrahepatic metastases. 4. ecog performance status 0-1. 5. alpha-fetoprotein (afp) decreased to normal，3-4 weeks after surgery. if it is not normal, it must be checked that there is no clear lesion in mri or ct. 6. adequate organ function. 7. patient has given written informed consent. exclusion criteria: 1. no anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery. 2. known history of hypersensitivity to macromolecular protein preparation or any components of the shr- 1210 formulation. 3. tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components; 4. subjects with any active autoimmune disease or history of autoimmune disease 5. uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 6. active infection or an unexplained fever \> 38.5°c during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 7. received a live vaccine within 4 weeks of the first dose of study medication. 8. pregnancy or breast feeding. 9. decision of unsuitableness by principal investigator or physician-in- charge.
epidemiology of stress and the metabolic syndrome

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity; Hypertension; Hyperinsulinism; Insulin Resistance; Metabolic Syndrome X

Summary: to examine the effects of psychological stress on the metabolic syndrome.

background: the metabolic syndrome identifies the clustering of lipid abnormalities, hypertension, hyperglycemia and abdominal obesity. it is a common and strong contributor to heart disease and diabetes and disproportionably affects older persons. animal and small clinical studies have suggested that psychosocial stress is a risk factor for the metabolic syndrome. underlying mechanisms may be through activation of the hypothalamopituitary-adrenal (hpa) axis causing hypercortisolemia, and, partly in turn, elevated inflammation and decreased sex hormone levels. however, longitudinal data showing that psychosocial stress indeed contributes to the onset and sequelae of the metabolic syndrome in the population at large, are lacking. design narrative: the primary objectives are to conduct data-analyses and biological sample analyses to examine the effect of psychosocial stress, as indicated by mood problems (depressive symptoms) and stressful social circumstances (poverty, negative life events, occupational stress, lack of emotional support), on the onset and sequelae of the metabolic syndrome. secondary objectives are to examine underlying biological mechanisms in the effect of psychosocial stress on the metabolic syndrome. the investigators will use available data from two ongoing longitudinal community-based studies among older persons: the health aging and body composition (health abc) study (n=3,075, mean age=74 years, 52%=female, 42% african american) and the inchianti study (n=1,453, mean age=69 years, 56%=female). in both studies psychosocial stress and the metabolic syndrome are well defined, longitudinal data on sequelae (cvd events and diabetes onset) and onset of the metabolic syndrome are available, and potentially underlying biological variables were, or will be, assessed including 24-h urinary cortisol, serum sex steroid hormones (estradiol, testosterone, shbg, dheas) and inflammatory markers (il-6, il-10, tnf-alpha, crp, and various soluble cytokine receptors). the results of this study will help in designing future intervention trials that evaluate whether reducing stress and/or its physiological consequences, either by pharmacological treatment or behavioral intervention, could reduce incidence of the metabolic syndrome in the older general population.

Eligibility criteria:
age \>70 years community swelling
impact of chronic cough on activities of daily living and response to acute high-intensity exercise

Conditions: Chronic Cough (CC)

Summary: chronic cough is a common and debilitating condition that affects up to 10% of the global population. the health impact of chronic cough is multifaceted and manifests both physical and psychological symptoms including syncope, chest pain, lethargy, depression and anxiety. it is now also recognised that chronic cough often leads to social isolation and may impact an individual's ability or confidence to undertake routine daily tasks / lead an active lifestyle. the primary aim of this study is therefore to characterise the impact of unexplained chronic cough on the ability to undertake daily activities - i.e., determine whether individuals with chronic cough exhibit impaired levels of physical activity during usual daily living when compared with healthy age, gender and bmi matched controls. a secondary aim is to assess the short-term impact of high-intensity exercise on cough (i.e., determine whether an acute bout of exercise alters cough frequency and/or severity).


Eligibility criteria:
inclusion criteria: * age \>18 years * chronic cough as per european respiratory society definition (\>8 weeks duration) * high symptom burden (i.e., cough visual analogue scale \>40 mm at pre-study screening) * chest radiograph or ct within 3 years of the screening visit with no abnormalities considered to contribute to chronic cough exclusion criteria: * smokers or individuals who gave up smoking within 12 months * smoking history \>20 pack-years * long-covid or post-covid syndrome (defined as symptoms lasting over 12-weeks in duration) * recent exacerbation of cough within 4 weeks of inclusion * respiratory tract infection within 4 weeks of inclusion * currently taking any of the following medications: * ace inhibitors and within 3 months of inclusion * antitussives (opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, or over the-counter medications) within 2 weeks of inclusion * medical treatments for gastro-oesophageal reflux disease (gord), eosinophilic bronchitis or other cough related conditions, initiated or changed (i.e., not in a stable regimen) for 4 weeks prior to inclusion * medical history of asthma or exercise-induced bronchoconstriction (eib), copd, or chronic bronchitis in the judgement of the investigator * medical conditions/history or other circumstances which, in the judgement of the investigators, could increase the risk of adverse events or bias the study results

Keywords: cough physical activity exercise physiology
pulmonary function changes in 10 pack year smokers with chronic bronchitis

Conditions: Chronic Bronchitis; COPD

Summary: to determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.

the incident of copd is dramatically increasing while other chronic disease states are decreasing in the us population. smoking cigarettes is the leading risk factor for copd. smokers with chronic bronchitis may show early or late changes of copd on pulmonary function tests. it is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.

Eligibility criteria:
inclusion criteria: 1. subjects must sign a written informed consent. 2. enrollment population would include males and females 40 years of age to 80 years of age. 3. current history or past history of smoking at least 10 pack years of cigarettes. 4. patients to satisfy the diagnosis of chronic bronchitis. 5. non-smokers will be allowed in the control group exclusion criteria: 1. chronic infections such as tb or other infections of the lungs. 2. collagen diseases such as rheumatoid arthritis or lupus which affect the lungs. 3. any previous lung diseases such as pneumoconiosis. 4. previous accidents or surgery which would involve the lungs or the ribcage. 5. maintenance medications used for asthma or copd such as long acting bronchodilators or inhaled corticosteroids. 6. asthma patients or other patients with allergies that may affect pulmonary function test will be excluded. 7. any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment. 8. pregnant woman will not be allowed 9. current participation in a research study or within the last 30 days.

Keywords: smokers chronic bronchitis pulmonary function test abnormalities copd
active screening of latent tb infection, treatment and long term follow-up in prison

Conditions: Tuberculosis

Summary: ltbi treatment is effective in prison

ltbi treatment will be conducted in a prison with either isoniazid or rifampin

Eligibility criteria:
inclusion criteria: * all people who is ltbi, and have ability to sign the informed concent exclusion criteria: * previously adverse effect from anti-tb medication complete treatment of tb in the pass; active tb ast, alt \> 3 times of normal limit platelet \ 2 times of normal limit
intravenous infusion of paracetamol for intrapartum analgesia of labor

Conditions: Labor Pain

Summary: this is a double-blind randomized trial evaluates the efficacy of intravenous infusion of paracetamol as intrapartum analgesic in the first stage of labour.

comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.

Eligibility criteria:
inclusion criteria: 1. age between 18-35 years. 2. primigravida. 3. the gestational age between 37- 42 weeks. 4. patient seeking analgesia. 5. single viable fetus. 6. vertex presentation. 7. spontaneous onset of labor. 8. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase). exclusion criteria: 1. extreme of age (below 18-above 35). 2. multiparity. 3. multiple gestation. 4. malpresentation. 5. major degree of cephalopelvic disproportion. 6. any medical disorder with pregnancy e.g., rheumatic heart disease, diabetes mellitus, hypertension, anemia. 7. induction of labor. 8. cervical dilatation exceeds exceeding 4 cm. 9. use of any other kind of analgesia before recruitment in the study. 10. scared uterus. 11. fetal distress. 12. antepartum hemorrhage. 13. intrapartum bleeding. 14. polyhydramnios. 15. pre-mature rupture of membranes. 16. intra uterine infections. 17. hypersensitivity to paracetamol.

Keywords: intravenous paracetamol intrapartum analgesia labor pain intrapartum pains
fsrt combined with tmz for large bms: a psm study

Conditions: Brain Metastases; Radiotherapy; Chemotherapy

Summary: a propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

a previous single arm phase ii trial of our institution has shown that hfsrt combined with concurrent tmz was safe and efficient for patients with bms of ≥ 6cc in volume. the 1-year local control and overall survival rate was better than the results of a retrospective study using hfsrt alone in treating bms of ≥ 3cm in diameter. thus, we hypothesized that adding tmz to hfsrt should translate to substantive benefits in clinical outcomes compared to hfsrt alone. propensity score matching method was adopted to decrease potential bias in this retrospective study.

Eligibility criteria:
inclusion criteria: * (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (mri) ; (2) age 18 years or older (3) kps ≥60, or kps ≥50 but symptomatically caused by bms; (4) the large lesions haven't treated with surgery or srt. exclusion criteria: * (1) kps \<60 but not caused by bms; (2) the large lesions have been treated with surgery or srt.
point-of-care ultrasound interest in acute gastrointestinal bleeding emergency department patients

Conditions: Acute Gastrointestinal Bleeding

Summary: acute gastrointestinal (gi) bleeding are a common chief complaint among emergency department. the mortality rate for lower gi bleeding is 3.9%. while the mortality rate can be as high as 10% for upper gi bleeding. most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. currently, few studies have examined the value of echocardiography in the management of patients presenting for acute gi bleeding in the emergency department. the main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the emergency department for acute gastrointestinal bleeding.


Eligibility criteria:
inclusion criteria: * primary reason for emergency department admission is acute gastrointestinal bleeding exclusion criteria: * pregnant or breastfeeding women * persons not benefiting from a social security scheme * persons deprived of liberty * patient participates in another study * the patient is in a period of exclusion determined by a previous study. * the patient is under legal protection, guardianship or trusteeship. * patient refuses to participate * it proves impossible to give informed information about the subject matter * the patient is not fluent in french.

Keywords: emergency department acute gastrointestinal bleeding echocardiography
edwards cardioband system active pivotal clinical trial (active)

Conditions: Functional Mitral Regurgitation; Mitral Regurgitation; Mitral Insufficiency

Summary: to establish the safety and effectiveness of the edwards cardioband system in patients with functional mitral regurgitation (fmr).

the active trial is a prospective, randomized, multicenter trial. patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the edwards cardioband system plus guideline directed medical therapy (gdmt) or gdmt alone. patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * clinically significant functional mitral regurgitation (mr); * symptomatic heart failure; * patient hospitalized due to heart failure during 12 months prior to submission to central screening committee or elevated brain natriuretic peptid (bnp); * patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance. exclusion criteria: * primarily degenerative mr; * mitral annular calcification that would impede implantation of device; * other severe valve disorders requiring intervention; * mitral valve anatomy which may preclude proper edwards cardioband deployment; * life expectancy of less than twelve months; * patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint; * unwillingness or inability to undergo follow-up investigations/visits; * other medical, social, or psychological conditions that precludes appropriate consent and follow-up

Keywords: edwards cardioband mitral valve transcatheter mitral repair functional mitral regurgitation secondary mitral regurgitation annuloplasty
do mind ease interventions reduce feelings of acute anxiety? a randomised controlled trial

Conditions: Anxiety

Summary: this study investigates the short-term effects of the mindease app on anxiety levels.

anxiety is a common symptom in the world's population (whiteford et al., 2013). it occurs as a symptom within other mental disorders and as a disorder in itself (american psychiatric association, 2013). there are several ways of dealing with anxiety, from short guidance for coping on a symptom level to professional health. (emmelkamp \& ehring, 2014). many people suffering from anxiety below a threshold indicating need for professional therapy may profit from strategies to calm down. (helmchen \& linden, 2000). among the strategies that are effective, there are guided interventions that people can use via a web-based interface on a computer or smartphone (taylor et al., 2021). while it is known for most interventions that they are helpful, it is often unclear if they work also in web-based environments (baumel et al., 2020). this is because most research regarding the topic investigates the effectiveness of mental-health apps as a whole, while research of specific interventions is missing (domhardt et al., 2019). however, to develop effective apps, it is crucial to identify which specific interventions are most efficient in a web-based setting. (domhardt et al., 2019; firth et al., 2017). therefore we want to identify interventions working effectively in an online format. mind ease is an app that offers different established interventions within one framework to their users when they feel anxious. this framework makes the different interventions comparable to each other. for this reason, we will test the interventions that are used in the mind ease-app. in a first study we will correlate the mind ease 3-sliders-score with the state-trait- anxiety-inventory (sai). in a second study we will measure participants'; acute anxiety (with the 3-sliders- score) before and after they performed a 10 minutes web-based cognitive or mindfulness-associated intervention. we will compare the anticipated reduction in anxiety to the reduction measured in participants in a control group. prospectively registered here: https://osf.io/36ukh

Eligibility criteria:
inclusion criteria: * anxiety score is above cut-off exclusion criteria: -

Keywords: anxiety app psychotherapy mindfulness acceptance and commitment therapy cognitive behavioural therapy randomised controlled trial depression
the effects of keeping the patient in a sitting position for one minute after spinal anesthesia

Conditions: Hypotension; Spinal Anaesthesia

Summary: the aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.


Eligibility criteria:
inclusion criteria: * aged 18 - 45 years, * asa physical status * i - ii, * bmi of 25-30 * who were undergoing elective cs exclusion criteria: * vertebral anomaly, * peripheral vascular disease, * cardiovascular or psychiatric disorder, * severe anemia, * coagulopathy * infection in the intervention region

Keywords: spinal anaesthesia ephedrine
gemcitabine for marginal zone lymphoma

Conditions: Non-Hodgkin's Lymphoma; Marginal Zone Lymphoma

Summary: marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. thus the investigators need a novel agent for marginal zone lymphoma. gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. to the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.

we designed a multi-center phase ii trial of gemcitabine for advanced stage marginal zone b-cell lymphoma. marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. recent trials with new agents for indolent lymphoma shows promising results. gemcitabine is known to have activity to non-hodgkin's lymphoma and has less adverse effects than other new agents. with this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma. gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. response will be assessed by iwc criteria.

Eligibility criteria:
inclusion criteria: * histologically confirmed marginal zone b-cell lymphoma * performance status (ecog) ≤3 * age ≥ 18 * at least one or more bidimensionally measurable lesion(s): * 2 cm by conventional ct * 1 cm by spiral ct * skin lesion (photographs should be taken) * measurable lesion by physical examination * laboratory values: * cr \ 60 ml/min * transaminase \< 3 x upper normal value * bilirubin \< 2 mg% * anc \> 1500/ul, platelet \> 75,000/ul * informed consent * ann arbor stage iii or iv exclusion criteria: * any other malignancies within the past 5 years except skin basal cell ca or cis of cervix * serious comorbid diseases * pregnancy or breast feeding

Keywords: marginal zone lymphoma gemcitabine